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On 17 March 2020 the U.S. Environmental Protection Agency (EPA) announced the availability of a prepublication of the Chemical Data Reporting (CDR) final rule pursuant to Section 8(a) of the Toxic Substances Control Act (TSCA). Most notably, the rule modernizes the CDR reporting requirements in light of the Frank R. Lautenberg Chemical Safety for the 21st Century Act amendments to the TSCA with minimal changes to the proposed CDR rule. Distinct to the proposal, updates on the treatment of the small manufacturing exemption for purposes of reporting under the CDR will be addressed in a separate rule. Further, businesses may expect to report under the CDR no later than 30 November 2020.
Verisk 3E Review
Manufacturers and importers report exposure-related data concerning substances listed on the TSCA inventory to the EPA every four years under the CDR. Until 30 November 2020 the EPA will collect the CDR submissions concerning chemicals manufactured between 2016 and 2019 in amounts of 25,000 pounds or more. However, businesses may start reporting to the EPA as early as 1 June 2020.
TSCA CDR to Align with Amended TSCA
The 2020 TSCA CDR cycle will be the first reporting event of its kind after the adoption of the 2016 amendments. As a result, the EPA had to revise the reporting rule to align the requirements to support the implementation of the new statutory requirements under TSCA. The revision to the requirements for claiming confidentiality via the CDR reporting is an example of a requirement that was updated to align with the 2016 TSCA amendments.
Changes to Confidentiality Claims
The EPA finalized the CDR rule to require upfront substantiation for all non-exempt confidential business information (CBI) claims. Reportable information on production volume and supplier information associated with a joint submission will be exempt from upfront substantiation. In the case of joint submissions, the EPA clarified that secondary submitters would be responsible for assessing all CBI claims for data it submits. Further, secondary submitters will also be responsible for substantiating data claimed as confidential. Thus, information that is not subject to upfront substantiation may still be subject to substantiation and CBI review at a later time per Section 14(f) of TSCA.
The rule also reminds submitters that the following information may not be claimed as confidential:
- Data that directly describes how a chemical is being used or processed, such as:
- The type of use of process
- The industrial sector
- The industrial function
- Data on how a chemical is used in a product category, particularly in commercial and consumer products
- Data on whether a chemical might likely be used in children’s products
- Data on the function of a chemical in commercial and consumer products
From the list above, it is notable and worth mention that the requirement to furnish data on the function of a chemical via joint submission is a new data element introduced by the agency, which is barred from confidentiality claims. Below, Verisk 3E provides further input for complying with this requirement.
Last, businesses may expect the revision made to the substantiation questions revised in the Procedures for Review of CBI Claims for the Identity of Chemicals on the TSCA Inventory rule (85 Fed. Reg. 13062; 6 March 2020) to apply to confidentiality claims made through the CDR reporting. Particularly, the EPA clarified that the substantiation questions on substantially competitive harm and the ability to reverse-engineer the chemical identity apply to the CDR reporting.
As specified above, the EPA introduced a new data requirement to collect the specific function of each chemical in the mixture in a joint submission and the percentage of the chemical in the imported product. In the past, primary submitters had the responsibility to report the function of the overall imported mixture and the chemicals present in the mixture. The 2020 CDR rule, however, shifts this responsibility to secondary submitters of a joint submitter after finding minimal risk of the burden on this action.
Mandatory Use of OECD-based Processing and Use Codes
Consistent with the original proposal, the EPA has replaced certain processing and use codes with the functional use and product and article use codes used by the Organization for Economic Cooperation and Development (OECD). The use of OECD-based codes will extend to reporting consumer and commercial use information. The agency, however, will use a phased approach to implement the use of these codes for purposes of the CDR reporting.
During the 2020 CDR reporting cycle all chemical substances that were identified in 2019 as high priority substances warranting risk evaluation will need to rely on the OECD-based codes, when appropriate. All other substances not identified as high priority substances in 2019 may voluntarily use the OECD-based codes during the 2020 CDR reporting period. The use of the OECD-based codes will be mandatory without exception for all reportable chemical substances during the 2024 CDR reporting period.
Voluntary Reporting of Byproduct Production Volume
The 2020 CDR reporting rule now contemplates the voluntary reporting of the percent of the total production volume of byproduct chemicals. Since reporting of this element is totally voluntary, the EPA clarified that these volumes might be reported in ranges.
Requirements for Processors and Small Manufacturers
While Section 8(a) of TSCA generally excludes small manufacturers and processors from the CDR reporting, the EPA may subject these businesses to the CDR reporting if they engage in commercial activities regulated under Sections 4, 5(b)(4), 5(e), 6, or 7 of TSCA. In order to address unique responsibilities applicable to these businesses, the agency will update the size standard definition for small manufacturers for reporting and recordkeeping requirements in a separate rule. This way the agency will be able to tailor responses specific to the small manufacturing community.
Last, all of the other CDR requirements were finalized as proposed. For more on these and all other changes finalized for purposes of the 2020 CDR reports, please refer to the prepublication of the rule.
Verisk 3E Analysis
The chemical industry was advised on these changes via prepublications of two rules: the TSCA Chemical Data Reporting Revisions under TSCA Section 8(a) and the Chemical Data Reporting; Extension of the 2020 Submission Period. While these rules have yet to take effect, deadlines loom soon for the CDR reporting, which starts as early as 1 June 2020. Last, businesses should be advised that the EPA has updated the e-CDR webpage for easy reporting using the Central Data Exchange (CDX) portal.